Director, Compliance

Responsibilities

• Design and implement a comprehensive health care compliance program consistent with all laws, regulations, policies and industry standards
• Establish and refresh corporate policies, procedures and guidelines to ensure compliant operations across Commercial, Medical and research activities
• Lead risk assessments to identify and prioritize compliance risks
• Develop and deliver risk-based compliance training for employees
• Develop and implement auditing & monitoring plans and related dashboards
• Lead confidential, thorough investigations into potential violations
• Collaborate closely with Franchise Counsel to align on consistent, actionable legal and compliance solutions
• Serve as a trusted advisor to senior leadership and cross-functional teams on business and compliance strategies

Requirements

• Advanced degree in law, business administration or related field
• 10+ years of overall professional experience
• 7+ years of healthcare compliance experience, ideally within a global rare disease biotechnology company
• Deep expertise in U.S. health care laws, federal health care programs, and therapy launches
• Strong understanding of PhRMA Code, Anti-Kickback Statute, False Claims Act, data privacy, and transparency laws
• Experience supporting compliant patient engagement, HCP engagement, scientific exchange, and innovative patient support programs
• Proven success advising cross-functional teams on complex, time-sensitive matters
• Experience thriving in a small, rapidly growing biotech or start-up environment

About the Company

Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease.